Actively Recruiting
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
Led by Michael McHale · Updated on 2024-08-12
90
Participants Needed
1
Research Sites
425 weeks
Total Duration
On this page
Sponsors
M
Michael McHale
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
CONDITIONS
Official Title
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed within 6 months of last platinum chemotherapy
- Histologic types eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma N.O.S.
- Must have had one prior platinum-based chemotherapy regimen including carboplatin, cisplatin, or other organoplatinum compounds
- No more than two total prior cytotoxic chemotherapy lines for recurrent or persistent disease
- May have had one additional non-cytotoxic treatment for recurrent or persistent disease
- Women of childbearing potential must have a negative pregnancy test and use effective contraception
- Adequate bone marrow, kidney, liver, and nerve function
- Recovered from recent surgery, radiation, or chemotherapy effects with toxicities ≤ Grade 1
- Free of active infections requiring antibiotics except uncomplicated urinary tract infection
- Hormonal therapy for cancer must be stopped at least one week before enrollment
You will not qualify if you...
- Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma
- Known second primary or prior malignancy diagnosed within 5 years except treated non-melanoma skin cancer
- Receiving chemotherapy or radiation therapy currently or within three weeks before enrollment
- History of treatment with kinase inhibiting agents
- History of gastrointestinal fistula, hemorrhage, perforation, or peptic ulcer disease
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California San Diego
San Diego, California, United States, 92023
Actively Recruiting
Research Team
M
Michael McHale, MD
CONTACT
A
Alexandrea Cronin, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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